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Completed

NCT Number: NCT01882088

Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD

Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation. These are caused by increasing number of transient lower esophageal sphincter relaxations, regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus and consequent esophageal mucosa damage. In addition, an important role is played by the increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of the contents from the stomach and increase of gastric and intra-abdominal pressure. All of these factors may depend on the patient's diet.

Theoretical premises of the positive influence of including dietary fiber on the course of gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide (NO) containing in food, which in turn has relaxing effects on the lower esophageal sphincter. In addition, fiber deficiency has been shown to be associated with increased chance of developing hiatal hernia, which is associated with greater risk of the disease manifestations. There is lack of data to confirm that dietary interventions like higher dietary fiber intake may lead to lower frequency of GERD symptoms and influence objective criteria (those, obtained during esophageal pH-impedance (here and further: pH - pondus hydrogenii, i.e. quantity of hydrogen, a scale to measure acidity of a solution) recording and high resolution esophageal manometry).

Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata (ispaghula, psyllium). High content of mucuses in the composition of psyllium seed allows it to include to group of soft food fibers, which has fundamental value for the appointment of a drug at a number of diseases, when, for example, the use of coarse food fibres not recommended or contraindicated.

Mucofalk is the registered medicinal (registration number of the Russian State register of medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma Gesellschaft mit beschränkter Haftung (GmbH), packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally, adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1 packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink immediately. Then drink another glass of liquid.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Institute of Nutrition of Russian Academy of Medical Sciences

Moscow, 115446, Russia

About this study

During the study 14-days screening period is provided to evaluate H.pylori and endoscopic status of the patient and to confirm the presence of dietary fiber deficiency (based on standard computerized dietary questionnaire). On the baseline physical examination, GERD-Q questionnaire, GERD symptom severity scale (by Likert), Bristol stool scale, high resolution esophageal manometry and 24-hours esophageal pH-impedance studies are to be provided. Since baseline, up to day 10 Mucofalk 15 g/day in three times a day (TID) regimen is to be given. All the patient will receive standardized menu. Repeat evaluation of symptoms, high resolution esophageal manometry and 24-hours esophageal pH-impedance are to be done at the day 10 of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease
  • Dietary fiber deficiency by dietary questionnaire
  • pathological gastroesophageal reflux by 24-hours esophageal pH-impedance examination
  • willingness to participate (signed informed consent)

Exclusion criteria

  • presence of esophageal mucosal damages (esophagitis) by endoscopic evaluation
  • gastrointestinal surgery in anamnesis
  • current pregnancy or breast-feeding
  • known hypersensitivity to Mucofalk or its components

Treatment and study plan

Mucofalk

Drug

Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Other names: Psyllium

Primary outcomes

  1. Number of Gastroesophageal Refluxes

    Time frame: End of Treatment, on day 10 of psyllium intake

    Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance on the 10th day of psyllium intake. Statistical data represent the results of the comparison of the data obtained on the day 10 of study (EOT) with the baseline characteristics provided in the specific section

Secondary outcomes

  1. Acid Exposure Time

    Time frame: End of Treatment, on day 10 of psyllium intake

    Percent of time with pH less than 4 at 5 cm above upper border of lower oesophageal sphincter per 24-hours oesophageal pH-impedance recording on the day 10 of psyllium intake. This outcome measure was compared to the baseline characteristics provided in the specific section of the study description

  2. Number of Acid Gastroesophageal Refluxes

    Time frame: End of Treatment, on day 10 of psyllium intake

    Number of acid refluxes was measured by 24-hours oesophageal pH-impedance recordings. Reflux was considered as acid when oesophageal pH was less than 4 and the impedance revealed backward flow of the stomach content into the oesophagus. Outcome measure reflects the data of day 10 of psyllium intake. Statistics reflects comparison between EOT and baseline data.

  3. Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake

    Time frame: 7 days prior to EOT

    Presence of heartburn during 7 days prior to the day 10 of psyllium intake was evaluated with a standardized questionnaire. This result was assessed at EOT

  4. Minimal Lower Esophageal Sphincter Pressure at Rest

    Time frame: End of Treatment, on day 10 of psyllium intake

    Obtained during esophageal high resolution manometry study. End of treatment data were compared to the baseline. Per standard, resting pressure is measured during 30 seconds. High resolution manometry data on day 10 was compared to baseline.

  5. Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake)

    Time frame: End of Treatment, on day 10 of psyllium intake

    The data are obtained during high resolution esophageal manometry study on the day 10 of psyllium intake. This outcome is measured after 10 water swallows by 5 ml each. The study usually lasts for about 15 to 20 minutes. Data of high-resolution esophageal manometry examination at baseline and on the day 10 of psyllium intake were compared.

  6. Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows

    Time frame: End of Treatment, on day 10 of psyllium intake

    The results obtained during high resolution esophageal manometry studies. This parameter is obtained after 10 water swallows by 5 ml each. Data of high resolution esophageal manometry (examination usually lasts for 10-20 min) on the day 10 of psyllium intake were compared to the baseline characteristics. The data were compared to baseline characteristics

  7. Residual Lower Esophageal Sphincter Pressure

    Time frame: End of Treatment, on day 10 of psyllium intake

    These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones.

Other outcomes

  1. Mean Lower Esophageal Sphincter Pressure (at Rest)

    Time frame: End of Treatment, on day 10 of psyllium intake

    This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake.

  2. Stools Per Week

    Time frame: 7 days

    Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Collaborators

  • Dr. Falk Pharma GmbH

Registry information

Official study title

Phase IV Non Comparative Study of the Impact of Dietary Fiber Deficiency Correction Using Mucofalk® on Clinical Features and Motor Function of the Esophagus in Patients With Non-erosive Gastroesophageal Reflux Disease

Acronym: OGIG-130-1

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2013
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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